2018 Volume 49 Issue 1 Pages 35-38
On 2 May 2017, NIH has released the “NIH and FDA Release Protocol Template for Phase 2 and 3 IND/IDE Clinical Trials” mainly for NIH and FDA funded Clinical Trials. We are now translating this template into Japanese for the improvement of research quality and integrity. We are also comparing the template with the Japanese Ethical Guidelines for Clinical Research Involving Humans. In this article, we would like to give a brief overview of our work. The template is consisted of 11 sections, each divided into several sub-sections. We have compared each section/sub-section with the information to be included in the protocol, as described in the Japanese Ethical Guideline. One of the feature is that there is a “Statement of Compliance” section at the beginning of the template to ensure that the researchers will conduct the trial following the basic premise, such as the accordance to ICH-GCP, Protocol and Informed Consent Form are reviewed by IRB prior to conduct of the trial, and so on. Also, the template guides to write the study procedures in detail, whereas the Japanese Guideline has not described in detail what information should be included within the study procedures. While on the other hand, there are some information the Japanese Guideline is mandating despite the stipulation of ICH-GCP : PI's contact information and available payment and compensation for the subjects. This information varies from site to site, as a consequence, each site is developing its own protocol for the same multi-center trial. This must be one of the topic to be discussed further ; how to distinctly write the mutual information and site-specific information.
